Peptide Regulatory Changelog Since January 2025
A dated list of FDA, HHS, court and state-board actions on peptides and GLP-1 drugs since January 2025, each with its primary source.
BPC-157Compounded versions: not FDA-approved
TB-500Compounded versions: not FDA-approvedAnimal studies only
EpitalonCompounded versions: not FDA-approved
SemaxCompounded versions: not FDA-approved
KPVCompounded versions: not FDA-approvedAnimal studies only
MOTS-cCompounded versions: not FDA-approvedAnimal studies only
SemaglutideFDA-approvedCompounded versions: not FDA-approved
TirzepatideFDA-approvedCompounded versions: not FDA-approved
RetatrutideInvestigational
CagrilintideInvestigational
Bremelanotide (PT-141)FDA-approved
GHK-CuCompounded versions: not FDA-approved
U.S. status checked
News, not medical advice. Full disclaimer.
What happened / Why it matters
What this is. A running, dated list of regulatory actions on peptides and GLP-1 drugs in the United States since January 2025, newest first. Each row names who acted, what changed and links to the primary source: an FDA page or letter, the Federal Register, a court-related FDA notice or a state board’s own notice.
Why it matters. Peptide rules are changing on several fronts at once: federal enforcement policy, FDA lists for compounding, warning letters, drug approvals and state licensing boards. A single dated list shows what changed, and what did not. It is not legal or medical advice.
How to read this list
- A policy is not an approval. HHS’s Oct. 30, 2026 policy says what HHS does not intend to enforce, under conditions. It is interim, open for public comment, and not FDA approval. Compounded drugs are not FDA-approved, and FDA does not review them for safety, effectiveness or quality before they are marketed.
- A warning letter is FDA’s position, not a ruling. We have not checked responses or later action.
- A board notice is not a statute. State notices are statements by licensing boards to their licensees. They predate the HHS policy, and we found no update from the boards on how they apply to it.
- Approvals are listed only for peptide drugs we cover, in the products and for the uses FDA approved. See each label.
- Dates are the dates of the action, not of news coverage.
Changelog
| Date | Who | What changed | Primary source |
|---|---|---|---|
| Nov. 13, 2026 (upcoming) | HHS | Public comments close on the interim peptide compounding policy (11:59 p.m. Eastern; 04:59 UTC Nov. 14). The docket was open and not withdrawn as of Nov. 3. | Regulations.gov |
| Oct. 30, 2026 | HHS | Publishes an interim enforcement discretion policy: HHS says it does not intend to take enforcement action against certain 503A compounding of six peptides (BPC-157, TB-500, epitalon, semax, KPV, MOTS-c), under conditions. It is not FDA approval and does not add them to the 503A list. | Federal Register |
| Oct. 30, 2026 | FDA | Latest warning letter to a telehealth company about compounded GLP-1 drugs that we found, part of a series of 111 since September 2025. | WL 737905 |
| Oct. 22, 2026 | FDA | Vyleesi (bremelanotide): label supplement updates section 8, Use in Specific Populations, based on the final report of a required postmarketing study; indication unchanged. | FDA approval letter |
| Oct. 1, 2026 | FDA | Updates its page on unapproved GLP-1 drugs. It says it is “not aware of any lawful basis” for compounding with semaglutide salts, and that retatrutide and cagrilintide cannot be used in compounding under federal law. | FDA |
| Sept. 18, 2026 | FDA | Warning letter to Empower Pharmacy: compounded tirzepatide-niacinamide and semaglutide-cyanocobalamin products “appear to be essentially copies” of approved drugs. | WL 738238 |
| Aug. 27, 2026 | FDA | Mounjaro: new indication to reduce major adverse cardiovascular events in adults with type 2 diabetes at high risk (S-44), and a new dosing regimen (S-45). | Drugs@FDA; label |
| Aug. 24, 2026 | FDA | Five warning letters to sellers of “research peptides”: FDA said the products are unapproved new drugs despite research-use labels. | WL 735067, WL 734884, WL 735063, WL 735127, WL 733652 |
| Aug. 19, 2026 | Mississippi | Boards of Nursing, Pharmacy and Medical Licensure jointly say “under no circumstances is it permissible for a healthcare provider to compound, administer, or dispense a non-FDA approved or research-grade peptide to a patient.” A board notice, issued before the HHS policy. | Joint statement |
| July 23-24, 2026 | FDA (advisory committee) | Pharmacy Compounding Advisory Committee meets on seven peptides for the 503A list. FDA’s drug center proposed listing none. Votes are reported only by a law firm (secondary): the committee backed six and did not back one. | FDA document; McDermott (secondary) |
| June 26, 2026 | FDA | Extends to July 30, 2026 the comment period on a proposal not to include semaglutide, tirzepatide or liraglutide on the 503B list. No final notice as of Nov. 3. | Federal Register |
| June 17, 2026 | FDA | Warning letter to a peptide seller: a product called Prostamax and a gonadorelin product are unapproved new drugs. | WL 729447 |
| June 15, 2026 | FDA | Updates its page for telehealth companies, which says promoting compounded drugs with false or misleading claims “violates federal law.” | FDA |
| May 26, 2026 (as reported) | Alabama | Board of Medical Examiners notice: “under no circumstances is it permissible for a physician to compound, administer, or dispense a non-FDA approved or research grade peptide.” The date is from local news reports; the board page does not show one. Issued before the HHS policy. | Board notice; news report (secondary) |
| May 14, 2026 | FDA | Updates its 503A bulk drug substances list. It anticipates an advisory committee meeting on GHK-Cu before the end of February 2027. | 503A list |
| May 1, 2026 | FDA | Proposes not to include semaglutide, tirzepatide or liraglutide on the 503B list. | Federal Register |
| Apr. 22, 2026 | FDA | FDA’s Category 2 page, updated April 22, 2026, lists BPC-157, TB-500, epitalon, MOTS-c, semax, KPV, LL-37, CJC-1295, AOD-9604, selank and thymosin alpha-1 among substances whose nominations were withdrawn. HHS says its six peptides were in Category 2 until April 22, 2026, and did not move to Category 1. Kisspeptin-10 (503A) and ipamorelin (503B) remain in Category 2. | FDA; HHS |
| Apr. 1, 2026 | FDA | Approves orforglipron (Foundayo), a daily tablet for weight reduction in adults with obesity or overweight plus a weight-related condition. It is a small molecule, not a peptide. | Drugs@FDA |
| Apr. 1, 2026 | FDA | Clarifies policies for compounders: semaglutide and tirzepatide are not on the 503B list or in shortage, and FDA says it does not intend to act on “essentially a copy” compounding if a compounder fills four or fewer prescriptions of the product in a month. | FDA |
| Mar. 31, 2026 | FDA | Five warning letters to sellers of GLP-1 drugs labeled for research: FDA said the products are unapproved new drugs. | WL 721805, WL 721709, WL 721600, WL 721088, WL 721806 |
| Mar. 19, 2026 | FDA | Wegovy: supplement approved for a new dosing regimen (S-29). See the current label. | Drugs@FDA; label |
| Feb. 2026 (month only) | FDA | Wegovy and Zepbound labels remove the suicidal behavior and ideation warning (“Recent major changes”). | Labels: Wegovy, Zepbound |
| Dec. 22, 2025 | FDA | Approves Wegovy tablets (NDA 218316), a new dosage form. | Drugs@FDA |
| Dec. 19, 2025 | FDA | Mounjaro: extends glycemic control in type 2 diabetes to patients 10 and older (S-39). | FDA approval letter |
| Dec. 8, 2025 | FDA | Warning letter to an API distributor: retatrutide is “a GLP-1 API that is not identified as an active ingredient in any drug approved by FDA,” and FDA said the firm distributed it to pharmacies seeking to compound. | WL 716152 |
| Nov. 21, 2025 | FDA | Wegovy: label adds a heart failure endpoint from its cardiovascular outcomes trial (SELECT), not controlled for type 1 error; “an effect on heart failure has not been established” (S-23). | FDA approval letter |
| Sept. 9, 2025 | FDA | First of 111 warning letters to telehealth companies about compounded GLP-1 drugs (55 that day). Letters also went that day to holders of approved semaglutide and tirzepatide applications about promotional videos FDA called false or misleading. | Letters: WL 715878; tracker of all letters |
| Aug. 15, 2025 | FDA | Wegovy: accelerated approval for non-cirrhotic MASH with stage F2-F3 fibrosis (S-24). | FDA approval letter |
| Apr. 24, 2025 | Court and FDA | The district court denies a preliminary injunction motion over semaglutide; FDA’s period of non-enforcement for 503A compounders of copies ends. For 503B outsourcing facilities it runs to May 22, 2025. | FDA |
| Mar. 5, 2025 | Court and FDA | The district court denies a preliminary injunction motion over tirzepatide; the 503A non-enforcement period ends. For 503B outsourcing facilities it runs to March 19, 2025. | FDA |
| Feb. 21, 2025 | FDA | Declares the shortage of semaglutide injection resolved. | FDA |
| Jan. 28, 2025 | FDA | Ozempic: new indication for chronic kidney disease in type 2 diabetes (S-25). | FDA approval letter |
What we are watching
- FDA’s final decision on the 503B list for semaglutide, tirzepatide and liraglutide.
- The close of comments on the HHS policy, and any revision of it.
- An advisory committee meeting on GHK-Cu and other peptides, which FDA anticipates before the end of February 2027.
- Whether Alabama or Mississippi update their notices after the HHS policy.
- FDA’s decision on CagriSema, which Novo Nordisk says it expects in the fourth quarter of 2026.
Limits
- The list covers actions we verified against primary sources. It is not every action, and we have not reviewed all 50 states.
- Dates marked “month only” appear on the label only as a month.
- The HHS policy page returns an error to automated readers; we read the policy text in the Federal Register and in an archived copy of the same file.
U.S. regulatory status checked Nov. 3, 2026. We add rows as actions occur and note changes with a visible date.
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Read the latest edition →Sources
- Federal Register: HHS Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances (Oct. 30, 2026)
- HHS policy with Appendices A and B
- FDA: Certain bulk drug substances for use in compounding that may present significant safety risks
- FDA: FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize
- FDA: FDA's concerns with unapproved GLP-1 drugs used for weight loss
- FDA warning letters (searchable list)
- Regulations.gov docket HHS-OASH-2026-0496
Written and edited by the Best Peptides Today Editorial Team. How we work.